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Tuesday, the FDA granted accelerated approval for ImmunoGen Inc’s (NASDAQ: IMGN) Elahere (mirvetuximab soravtansine-gynx) for folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or main peritoneal most cancers.
HC Wainwright says the permitted label doesn’t require a previous remedy with bevacizumab, which in accordance with administration, may practically double the eligible affected person inhabitants.
The analyst elevated the value goal from $12 to $20, with a Purchase score.
Elahere’s broader-than-expected label would possibly consequence from the FDA’s entry to preliminary goal response price (ORR) and period of response (DOR) information from each arms of the MIRASOL examine.
Elahere’s label features a boxed warning for ocular toxicities, however HC Wainwright believes it might have a restricted impression on Elahere’s adoption.
Every 21-day cycle remedy would price $18,000-$25,000, with an annual price of $182,400 per affected person.
BMO Capital Markets says ImmunoGen shares had been below stress (-13% vs. -0.26% XBI) following the Elahere approval convention name, which was a shock.
BMO analyst raised the value goal from $17 to $19 on incrementally extra optimistic on MIRASOL information in early 2023.
The analyst expects mirvetuximab can solely obtain ~$300 million peak gross sales, undervaluing the ovarian most cancers alternative.
Value Motion: IMGN shares are up 5.09% at $5.27 on the final test Wednesday.
Date | Agency | Motion | From | To |
---|---|---|---|---|
Feb 2022 | SVB Leerink | Maintains | Market Carry out | |
Feb 2022 | BMO Capital | Initiates Protection On | Outperform | |
Dec 2021 | Jefferies | Upgrades | Maintain | Purchase |
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